Trial · NCT04023526
A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy
NCT04023526, Phase 2, Active not recruiting, OncoVerity, Inc.; results first posted 2024-07-30
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy. Trials, record NCT04023526. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04023526
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy
- NCT number
- NCT04023526
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 103 participants, actual
- Lead sponsor
- OncoVerity, Inc.
- Conditions
- Leukemia, Myeloid, Acute
- Interventions
- Azacitidine, Cusatuzumab
- First posted
- 2019-07-17
- Last updated
- 2026-10-30
- Other registries' IDs
- eudract:2019-000473-23
- Results first posted
- 2024-07-30
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete Remission (CR) | Up to 3 years and 5 months | Complete remission based on European Leukemia Network (ELN) 2017 response criteria. Defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absences of extramedullary disease; ANC \>= 1.0 x10\^9/L; platelet count \>=100 x 10\^9/L |
| Secondary | Percentage of Participants With CR With Partial Hematological Recovery (CRh) | Up to 3 years and 5 months | CRh defined as meeting all criteria for CR except ANC \>0.5x10\^9/L and platelet count \>50x10\^9/L |
| Secondary | Percentage of Participants With CR Plus CRh | Up to 3 years and 5 months | CR plus CRh based on ELN 2017 response criteria. CR defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absences of extramedullary disease; ANC \>= 1.0 x10\^9/L; platelet count \>=100 x 10\^9/L CRh defined as meeting all criteria for CR except ANC \>0.5x10\^9/L and platelet count \>50x10\^9/L |
| Secondary | Percentage of Participants With CR With Incomplete Recovery (CRi) | Up to 3 years and 5 months | CRi based on ELN 2017 response criteria. Defined as meeting all CR criteria except for residual neutropenia (ANC \<1.0x10\^9/L) or thrombocytopenia (platelets \<100x10\^9/L) |
| Secondary | Overall Response Rate (ORR) | Up to 3 years and 5 months | ORR is defined as percentage of participants with CR, CRh and CRi based on ELN 2017 response criteria. |
| Secondary | Percentage of Participants With CR Without MRD | Up to 3 years and 5 months | CR without minimal residual disease (MRD) defined as less than 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level \<10\^-3 by flow cytometry). |
| Secondary | Percentage of Participants With Negative MRD Who Achieved CR, CRh, CRi, or Morphologic Leukemia-free State (MLFS) | Up to 3 years and 5 months | Percentage of participants with negative MRD who achieved CR, CRh, CRi, or MLFS will be reported and is defined as less than (\<) 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level \<10\^-3). |
| Secondary | Time to First Response | Up to 3 years and 5 months | Defined as time from randomization to achieving the first response of CR, CRh, or CRi. |
| Secondary | Duration of First Response | Up to 3 years and 5 months | Defined as time from achieving the first response of CR, CRh, or CRi to disease relapse or death from any cause. |
| Secondary | Red Blood Cell (RBC) and/or Platelets Transfusion Independence | Up to 3 years and 5 months | Defined as a period of at least 56 consecutive days with no transfusion of RBC and/or platelets between first dose of study drug and the last dose of study drug +30 days. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete Remission (CR) | Up to 3 years and 5 months | Intention-to-treat (ITT) | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With CR With Partial Hematological Recovery (CRh) | Up to 3 years and 5 months | ITT | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With CR Plus CRh | Up to 3 years and 5 months | ITT | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With CR With Incomplete Recovery (CRi) | Up to 3 years and 5 months | ITT | percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) | Up to 3 years and 5 months | ITT | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With CR Without MRD | Up to 3 years and 5 months | ITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Negative MRD Who Achieved CR, CRh, CRi, or Morphologic Leukemia-free State (MLFS) | Up to 3 years and 5 months | |||
| SECONDARY | Time to First Response | Up to 3 years and 5 months | Responder population: Participants who achieved CR, CRh or CRi | Months | MEDIAN |
| SECONDARY | Duration of First Response | Up to 3 years and 5 months | Responder population: Participants who achieved CR, CRh or CRi | Months | MEDIAN |
| SECONDARY | Red Blood Cell (RBC) and/or Platelets Transfusion Independence | Up to 3 years and 5 months | ITT | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Complete Remission (CR) | Cusatuzumab 10 mg/kg Plus Azacitidine | 11.76 | 95% Confidence Interval 5.5 to 23.4 | percentage of participants | |
| Percentage of Participants With Complete Remission (CR) | Cusatuzumab 20 mg/kg Plus Azacitidine | 26.92 | 95% Confidence Interval 16.8 to 40.3 | percentage of participants | |
| Percentage of Participants With CR With Partial Hematological Recovery (CRh) | Cusatuzumab 10 mg/kg Plus Azacitidine | 9.8 | 95% Confidence Interval 4.3 to 21 | percentage of participants | |
| Percentage of Participants With CR With Partial Hematological Recovery (CRh) | Cusatuzumab 20 mg/kg Plus Azacitidine | 7.7 | 95% Confidence Interval 3 to 18.2 | percentage of participants | |
| Percentage of Participants With CR Plus CRh | Cusatuzumab 10 mg/kg Plus Azacitidine | 21.6 | 95% Confidence Interval 12.5 to 34.6 | percentage of participants | |
| Percentage of Participants With CR Plus CRh | Cusatuzumab 20 mg/kg Plus Azacitidine | 34.6 | 95% Confidence Interval 23.2 to 48.2 | percentage of participants | |
| Percentage of Participants With CR With Incomplete Recovery (CRi) | Cusatuzumab 10 mg/kg Plus Azacitidine | 7.8 | 95% Confidence Interval 3.1 to 18.15 | percentage of participants | |
| Percentage of Participants With CR With Incomplete Recovery (CRi) | Cusatuzumab 20 mg/kg Plus Azacitidine | 5.8 | 95% Confidence Interval 2 to 15.6 | percentage of participants | |
| Overall Response Rate (ORR) | Cusatuzumab 10 mg/kg Plus Azacitidine | 29.4 | 95% Confidence Interval 18.7 to 43 | percentage of participants | |
| Overall Response Rate (ORR) | Cusatuzumab 20 mg/kg Plus Azacitidine | 40.4 | 95% Confidence Interval 28.2 to 53.9 | percentage of participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cusatuzumab 10 mg/kg Plus Azacitidine | 51 | |
| Overall Study | STARTED | Cusatuzumab 20 mg/kg Plus Azacitidine | 52 | |
| Overall Study | COMPLETED | Cusatuzumab 10 mg/kg Plus Azacitidine | 46 | |
| Overall Study | COMPLETED | Cusatuzumab 20 mg/kg Plus Azacitidine | 42 | |
| Overall Study | NOT COMPLETED | Cusatuzumab 10 mg/kg Plus Azacitidine | 5 | |
| Overall Study | NOT COMPLETED | Cusatuzumab 20 mg/kg Plus Azacitidine | 10 |
Source ClinicalTrials.gov
Adverse events304
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cusatuzumab 10 mg/kg Plus Azacitdine | 26 | 51 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cusatuzumab 20 mg/kg Plus Azacitidine | 30 | 51 | |
| other | Anaemia | Blood and lymphatic system disorders | Cusatuzumab 10 mg/kg Plus Azacitdine | 24 | 51 | |
| other | Anaemia | Blood and lymphatic system disorders | Cusatuzumab 20 mg/kg Plus Azacitidine | 18 | 51 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cusatuzumab 10 mg/kg Plus Azacitdine | 20 | 51 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cusatuzumab 20 mg/kg Plus Azacitidine | 21 | 51 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cusatuzumab 10 mg/kg Plus Azacitdine | 13 | 51 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cusatuzumab 20 mg/kg Plus Azacitidine | 16 | 51 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cusatuzumab 10 mg/kg Plus Azacitdine | 11 | 51 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cusatuzumab 20 mg/kg Plus Azacitidine | 9 | 51 |
1 to 10 of 304Source ClinicalTrials.gov
See all 304 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cusatuzumab 10 mg/kg Plus Azacitdine | 39 | 51 |
| Total, all-cause mortality | Cusatuzumab 20 mg/kg Plus Azacitidine | 30 | 51 |
| Total, other adverse events | Cusatuzumab 10 mg/kg Plus Azacitdine | 51 | 51 |
| Total, other adverse events | Cusatuzumab 20 mg/kg Plus Azacitidine | 50 | 51 |
| Total, serious adverse events | Cusatuzumab 10 mg/kg Plus Azacitdine | 44 | 51 |
| Total, serious adverse events | Cusatuzumab 20 mg/kg Plus Azacitidine | 40 | 51 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37914483 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cusatuzumab 10 mg/kg Plus Azacitidine vs Cusatuzumab 20 mg/kg Plus Azacitidine: Percentage of Participants With CR Without MRD | Trial comparisons |
| Cusatuzumab 10 mg/kg Plus Azacitidine vs Cusatuzumab 20 mg/kg Plus Azacitidine: Number of Participants With Anti-cusatuzumab Antibodies | Trial comparisons |
| Cusatuzumab 10 mg/kg Plus Azacitdine vs Cusatuzumab 20 mg/kg Plus Azacitidine: deaths from any cause | Trial comparisons |
| Cusatuzumab 10 mg/kg Plus Azacitdine vs Cusatuzumab 20 mg/kg Plus Azacitidine: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04023526
GET https://conductscience.org/api/trials/v1/NCT04023526/results?page=2